MAUDE Adverse Event Report: C B FLEET CO INC DENTEK MAXIMUM PROTECTION DENTAL GUARD; MOUTHGUARD

Catalog Number 00027701203G

Device Problem Insufficient Information (3190)

Patient Problem Choking (2464)

Event Type  Injury  

Event Description

Initial ((b)(6)2021): this serious case reported via e-mail refers to a male hospice consumer who has two teeth missing on the left side and one tooth missing on the right side of his mouth.Age and medical history were not reported.On an unreported date, the consumer used the dentek maximum protection dental guard to treat an unknown indication.On the second night of use, the consumer accidentally ingested the dental guard and choked on it.It did not go all of the way into his stomach and was sticking out in his esophagus.He was first taken to the emergency department (ed) then transferred to a different hospital for removal of the dental guard by an ent physician and discharged later that day.The consumer is still recovering from the procedure.Meddra version (b)(4).Expectedness: foreign body in throat: unexpected.Accidental device ingestion: unexpected.Product used for unknown indication.According to the company reference safety information.

Event Description

Initial ((b)(6) 2021): this serious case reported via e-mail refers to a male hospice consumer who has two teeth missing on the left side and one tooth missing on the right side of his mouth.Age and medical history were not reported.On an unreported date, the consumer used the dentek maximum protection dental guard to treat an unknown indication.On the second night of use, the consumer accidentally ingested the dental guard and choked on it.It did not go all of the way into his stomach and was sticking out in his esophagus.He was first taken to the emergency department (ed) then transferred to a different hospital for removal of the dental guard by an ent physician and discharged later that day.The consumer is still recovering from the procedure.Meddra version (b)(4).Expectedness: foreign body in throat: unexpected.Accidental device ingestion: unexpected.Product used for unknown indication.According to the company reference safety information.

• Brand Name: DENTEK MAXIMUM PROTECTION DENTAL GUARD
• Type of Device: MOUTHGUARD
• Manufacturer (Section D): C B FLEET CO INC; 4615 murray place; lynchburg VA 24502
• MDR Report Key: 13509712
• MDR Text Key: 285459707
• Report Number: 1719513-2021-01497
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00027701203G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male